Lung Transplantation: Planning Grants for Clinical Trials of Novel Therapies (R34)

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Purpose. The National Heart, Lung, and Blood Institute (NHLBI) invites applications to support the initial organization, protocol development, and necessary preliminary studies critical for the design of robust clinical trials in lung transplantation. This Funding Opportunity Announcement (FOA) should be used to position investigators or groups of investigators to develop competitive clinical trials to test important new strategies to enhance the quality of lungs available for transplant and improve management and long term outcomes of lung transplant recipients. This may include assembling a research team, consisting of a principal clinical site and having several collaborating ancillary sites, defining and prioritizing research questions, collecting information on the feasibility of the therapy and patient availability, and developing protocol(s). Applications must demonstrate that the proposed work is both necessary and sufficient to permit proceeding to the design of important clinical trial(s). During the evaluation of applications in response to this FOA, the review group will also consider the significance and potential impact of the full-scale clinical trial(s) that would be proposed following the R34 award period. Of most importance, the NHLBI anticipates that the R34 award period will yield competitive investigator-initiated clinical trial grant applications that evaluate interventions for the treatment of complications during and after lung transplantation. Mechanism of Support. This FOA will utilize the R34 grant mechanism. Funds Available and Anticipated Number of Awards. The NHLBI intends to commit approximately $1,500,000 total costs for FY2010. The total amount to be awarded for this program will be a maximum of $3,000,000 total costs for the 2-year project period. It is anticipated that NHLBI will fund up to 2 awards.

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